Class 2 Device Recall Lorad

• Date Initiated by Firm: January 14, 2004
• Date Posted: August 11, 2004
• Recall Status: Terminated on September 15, 2004
• Recall Number: Z-0149-04
• Recall Event ID: 29764
• 510(K)Number: K011987
• Product Classification: System, X-Ray, Mammographic - Product Code IZH
• Product: Lorad MIV Platinum Mammograpgy System
• Code Information: S/N''s :18005960001 to 18010034196
• Recalling Firm/ Manufacturer: Lorad, A Division of Hologic; 36 Apple Ridge Rd; Danbury CT 06810-7301
• For Additional Information Contact: Luis Nesprido; 203-731-8360
• Manufacturer Reason for Recall: System failed to meet the mA's accuracy specfications at low mA's values
• FDA Determined Cause: Other
• Action: Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZH and Original Applicant = LORAD, A HOLOGIC CO.